Provision of Telemedicine Medication Abortion Without In-Person Tests: Results From a Clinical Study in Ukraine, Uzbekistan, and Azerbaijan

New published research shows that provision of medication abortion by telemedicine without in-person tests is safe, feasible and acceptable to women and providers in Ukraine, Uzbekistan, and Azerbaijan. Among the 300 eligible women interested in managing their abortion this way, nearly all got the abortion medications the same day as their first contact with the clinic, the majority had a complete abortion using the medication provided (Ukraine 96%; Uzbekistan 98%; Azerbaijan 98%), and few attended a clinic for an in-person visit. Following completion of the clinical study, our partners in Ukraine remained active in policy-related initiatives that resulted in changes to national abortion guidelines to include telemedicine services.

Evaluation of Telemedicine Medical Abortion Using a No-Test Protocol in the Eastern Europe and Central Asian Region: Evidence From Ukraine, Uzbekistan, and Azerbaijan Tsereteli T, Platais I, Maru M, Maystruk G, Kurbanbekova D, Rzayeva G, Winikoff B; Int J Gynaecol Obstet 2024

Can Oral Misoprostol Tablets Replace Oxytocin Infusion When Inducing Labor in Women With Pregnancies Complicated by Hypertension? Results From a Randomized Trial in India

Low-dose oral misoprostol is an effective option for inducing labor in pregnancies complicated by hypertension, according to a study conducted across three government hospitals in Nagpur and the surrounding area. The results show similar cesarean section rates (misoprostol 32% v. oxytocin 27%), the primary outcome, among 520 birthing parents randomized to continue taking misoprostol orally or switch to intravenous oxytocin infusion if they experienced inadequate contractions after taking oral misoprostol to prepare the cervix for vaginal delivery. There were no cases of uterine hyperstimulation. Prior research by the same group (University of Liverpool, Gynuity, and clinical sites in central India) established low-dose oral misoprostol as an optimal method for cervical ripening, a method recommended by the World Health Organization.

Oral Misoprostol Alone, Compared With Oral Misoprostol Followed by Oxytocin, in Women Induced for Hypertension of Pregnancy: A Multicentre Randomised Trial Mundle S, Lightly K, Durocher J, Bracken H, Tadas M, Parvekar S, Shivkumar PV, Faragher B, Easterling T, Leigh S, Turner M, Alfirevic Z, Winikoff B, Weeks AD; BJOG 2024

Foley Catheterisation Versus Oral Misoprostol for Induction of Labour in Hypertensive Women in India (INFORM): A Multicentre, Open-Label, Randomised Controlled Trial Mundle S, Bracken H, Khedikar V, Mulik J, Faragher B, Easterling T, Leigh S, Granby P, Haycox A, Turner MA, Alfirevic Z, Winikoff B, Weeks AD; The Lancet 2017

Gynuity has been conducting exploratory clinical research into existing medications that might be alternatives to mifepristone-misoprostol medication abortion regimens and useful where access to mifepristone is restricted or its supply is interrupted. We have been pursuing two possible options: the results from one study undertaken in Utah are available here and the promising findings from another, completed in 2023 at clinics in Mexico, are expected to be published later this year. We are planning further research activities relating to the latter study. 

Single Dose Letrozole and Misoprostol for Termination of Pregnancy Through 63 days’ Gestation: A Pilot Study Shochet T, Turok D, Frye LJ, Sexsmith CD, Gawron LM, Kaiser JE, Winikoff B; Contraception 2022

Preparation for a new study is in progress with partner clinics in Mexico to assess two regimens for treatment of early missed menses, a potential option for inducing menstruation following a missed period to ensure a state of non-pregnancy. Building on insights gained from a pilot study that evaluated a new ‘period pills’ regimen using medicines currently registered and available in Mexico, enrollment in the larger randomized trial is expected to begin this summer. This option could expand choice to people with late periods who do not want to be pregnant and prefer not to know their pregnancy status before taking medications to bring back their menses.

A collaborative research project is underway in Uganda to develop and evaluate the feasibility of a smartphone app designed to prompt women and/or their birthing companions to seek immediate help if they identify early warning signs and symptoms which might suggest a complication during the first 24 hours after childbirth. The project draws on previous research, including a Gynuity-led study which found that a fifth of women who underwent treatment for postpartum hemorrhage at study hospitals in Uganda had initially identified the heavy bleeding on their own or with support from their companions.

The Effectiveness and Safety of Introducing Condom-Catheter Uterine Balloon Tamponade for Postpartum Haemorrhage at Secondary Level Hospitals in Uganda, Egypt, and Senegal: A Stepped Wedge, Cluster-Randomised Trial Anger HA, Dabash R, Durocher J, Hassanein N, Ononge S, Frye LJ, Diop A, Beye SB, Burkhardt G, Darwish E, Ramadan MC, Kayaga J, Charles D, Gaye A, Eckardt M, Winikoff B; BJOG 2019

A new program was launched in Washington state to train pharmacists on screening for medication abortion eligibility, prescribing abortion pills, and dispensing them from pharmacy stores. Gynuity’s work that supports streamlining medication abortion provision helped pave the path for this type of program. Use of our sample protocol offering guidance on the provision of medication abortion without routine facility-based tests before or after treatment is cited by the program implementers as a resource guide for their pharmacist training.

Commentary: "No-Test" Medication Abortion: A Sample Protocol for Increasing Access During a Pandemic and Beyond Raymond EG, Grossman D, Mark A, Upadhyay UD, Dean G, Creinin MD, Coplon L, Perritt J, Atrio JM, Taylor D, Gold M; Contraception 2020

Evaluation of Telemedicine Medical Abortion Using a No-Test Protocol in the Eastern Europe and Central Asian Region: Evidence From Ukraine, Uzbekistan, and Azerbaijan Tsereteli T, Platais I, Maru M, Maystruk G, Kurbanbekova D, Rzayeva G, Winikoff B; Int J Gynaecol Obstet 2024

Oral Misoprostol Alone, Compared With Oral Misoprostol Followed by Oxytocin, in Women Induced for Hypertension of Pregnancy: A Multicentre Randomised Trial Mundle S, Lightly K, Durocher J, Bracken H, Tadas M, Parvekar S, Shivkumar PV, Faragher B, Easterling T, Leigh S, Turner M, Alfirevic Z, Winikoff B, Weeks AD; BJOG 2024

Failure of the Law to Grant Access to Legal Abortion in Chile Suárez-Baquero DFM, Dzuba IG, Romero M, Baba CF, Biggs MA; Health Equality 2024

Map of Mifepristone Approvals - Gynuity Health Projects Updated May 2024. Our latest information relating to mifepristone and its approval by country and by year

The Supreme Court voted last week 9-0 against a lawsuit by opponents of abortion, ruling that the plaintiffs do not have the standing to challenge the FDA’s actions regarding the regulation of mifepristone. We welcome the decision, but we remain vigilant. The evidence and data that we and other scientists work hard to produce continue to be important counterweights to irresponsible pseudoscience. Gynuity’s pathbreaking efforts to broaden access to medication abortion and remove regulatory restrictions on mifepristone in the U.S. have included:

• Completing seminal clinical research demonstrating that medication abortion using mifepristone and misoprostol is safe, effective, and desirable to patients.

• Providing data to support the FDA’s 2016 decision to expand outpatient medication abortion through 70 days of pregnancy.

• Providing data to support the FDA’s 2021 decision to remove the in-person dispensing requirement for mifepristone, allowing counseling and prescription through telemedicine appointments and mailing of the abortion medication.

Our work is far from over, and your urgent support is needed now more than ever.

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